Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients

Recruiting now · Not applicable

Conditions studied: Non-alcoholic Fatty Liver Disease (NAFLD), Alcoholic Liver Disease (ALD), Liver Fibrosis

In brief

The primary objective of the SOPRANO study is to compare two blood fibrosis tests, the eLIFT and the FibroMeter, for the screening of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care centers.

Key facts

Study ID

NCT05699018

Run by

University Hospital, Angers

People needed

1788

Starts

2023-03-13

Expected to finish

2026-09-12

Last updated by the study team

2026-06-30

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• NAFLD and/or ALD patient defined by at least 1 of the following criteria:
• Excessive alcohol consumption: higher than 210 g / week (men), or 140 g / week (women)
• Type 2 diabetes
• at least 2 metabolic factors among BMI higher than or equal to 25 kg / m 2; Elevated blood pressure (antihypertensive drug, or systolic blood pressure higher than or equal to 130mmHg, or diastolic blood pressure higher than or equal to 85mmHg), Dyslipidemia (lipid-lowering drug, or HDL cholesterol lower to 40mg/dl (men) / 50mg/dl (women), or triglycerides higher than or equal to150mg/dl); Hyperferritinemia (higher than upper limit of normal from the laboratory)
• Bright liver at ultrasonography without steatosis-inducing drug(systemic corticosteroids, tamoxifen, amiodarone, methotrexate)
• Following a protocol amendment, the 3 last investigating primary care centres will include NAFLD and/or ALD patients according to these updated criteria:
• Excessive alcohol consumption: >210 g/week in men or >140 g/week in women,
• AND/OR type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments,
• AND with the following stratification:
• 30% with excessive alcohol consumption 65% with type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments 5% with both conditions (excessive alcohol consumption, AND type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments)
• Patient's agreement to have a blood sample collected in a local laboratory participating in the study
• Subjects covered by or having the rights to medical care assurance
• Written informed consent obtained from subject

You may not qualify if…

• Already ongoing specialized follow-up for a chronic liver disease
• Altered health status with poor short-term prognosis, not compatible with a screening procedure
• Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome)
• Acute infection
• Pregnancy, breastfeeding
• Persons in detention by judicial or administrative decision
• Person admitted to a health or social establishment for purposes other than research
• Person subject to a legal protection measure
• Person unable to express consent

Where it is running

• BAUGE — Baugé-en-Anjou, France (enrolling)
• CHU Angers — Angers, France
• BECON — Bécon-les-Granits, France
• Chalonnes — Chalonnes-sur-Loire, France
• COMBOURG — Combourg, France
• LIFFRE — Liffré, France
• Montreuil — Montreuil-Bellay, France
• RENNES - Armagnac, Churchill — Rennes, France
• RENNES - Kennedy — Rennes, France
• CHU Rennes — Rennes, France
• SEGRE — Segré, France
• ANGERS — Angers, France
• Val Couesnon — Val-couesnon, France

Full record on ClinicalTrials.gov

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